COVID-19 trials registries data warehouse

http://ensaiosclinicos.gov.br/rg/RBR-8zg5rg7

Paulo Brofman

paulo.brofman@pucpr.br

2022-03-03

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

Both sexes, aged 18 - 70 years old, hospitalized patients, radiological diagnosis of viral pneumonia, virological diagnosis of SARS-CoV-2 infection by PCR, with noninvasive ventilatory support, PaO2 / FIO2 ratio between 200 and 300, C-reactive protein and ferritin above the reference value considered normal, use of corticosteroids in the dose recommended by the literature (CoDex or Recovery Protocols)

Contraindications for use of corticosteroids, immunosuppressive and antiviral treatment, morbid obesity (BMI> 35), multiple organ dysfunction syndrome, pre-malignant neoplastic conditions with life expectancy lower than 1 year old, pre-existing chronic illnesses like chronic dialysis kidney disease, chronic liver disease, congestive heart failure Class IV, pre-existing thromboembolic pathology, pre-existing severe allergic reaction, history of HIV and tuberculosis, enrollment in another clinical trial, pregnancy or breastfeeding

2

Pontifícia Universidade Católica do Paraná

18

70

Brazil

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

0

The expected primary outcome is safety in the use of intravenously infused CTM-TCU suspension in patients with pneumonia caused by SARS-CoV-2.

Phase 1/Phase 2

[{"arm_notes": "", "treatment_id": 1334, "treatment_name": "Umbilical cord mesenchymal stem cells", "treatment_type": "Advanced therapy medicinal products (atmp)", "pharmacological_treatment": "Biological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]